CTRI/2012/12/003242进行中（未招募）3 期
A Long-Term Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole (OPC 14597) as Maintenance Treatment in Adolescent Patients with Schizophrenia - Attain
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Written informed consent/assent obtained from a legally
- •acceptable representative (e.g., guardian) prior to the
- •initiation of any protocol-required procedures. In addition,
- •the subject must provide informed assent at screening and
- •must be able to understand that he or she can withdraw
- •from the study at any time. All informed consent/assent
- •procedures must be in accordance with the study centerâ??s
- •institutional review board/ethics committee (IRB/IEC)
- •and local regulatory requirements.
- •2. Male and female subjects aged 13 to 17 years, inclusive,
- •at the time of informed consent/assent until randomization
- •in Phase 3.
- •3. Subjects with a current diagnosis of schizophrenia, as
- •defined by DSM-IV-TR criteria and confirmed by the
- •K-SADS-PL, and a history of the illness (diagnosis or
- •symptoms) for at least 6 months prior to screening (as per
- •subject, family, or healthcare provider, or by previous
- •medical records). The initial diagnosis of schizophrenia
- •must be made and documented initially by an adequately
- •trained clinician (e.g. adolescent psychiatrist or local
- •medical equivalent), and the diagnosis should be
- •confirmed afterwards by utilizing the K-SADS-PL
- •performed by an adequately trained clinician.
- •4. Subjects who, in the investigatorâ??s judgment, require
- •treatment with antipsychotic medication(s).
- •5. Subjects who have shown previous response to
- •antipsychotic treatment (other than clozapine unless
- •clozapine is the only available treatment) and are not
- •resistant to treatment with other antipsychotics, according
- •to the investigatorâ??s clinical judgment.
- •6. Subjects who are currently being treated with oral or
- •depot antipsychotics other than clozapine, unless
- •clozapine is the only available treatment and subjects are
- •not resistant to treatment with other antipsychotics.
- •7. Subjects with a history of relapse and/or exacerbation of
- •symptoms when they are not receiving antipsychotic
- •8. Inpatient or outpatient status.
- •9. Ability of the subject and the subjectâ??s legally acceptable
- •representative (e.g., guardian) or caregiver(s) to
- •comprehend and satisfactorily comply with the protocol
- •requirements (including the prescribed dosage regimens,
- •tablet ingestion, and discontinuation of prohibited
- •concomitant medications), to read and understand the
- •written word in order to complete subject-reported
- •outcomes measures, and to reliably rate assessment scales.
- •10. Females of childbearing potential must have a negative
- •pregnancy test, must be practicing acceptable double
- •barrier methods of contraception (or can confirm
- •abstinence), and must not be pregnant or lactating.
- •11. Subjects who are receiving antipsychotic(s) other than
- 另有 8 项未显示
排除标准
- •Sex and Reproductive Status
- •1. Sexually active males who are not practicing double-barrier
- •birth control or who will not remain abstinent during the
- •study and for 90 days following the last dose of study
- •medication, or sexually active females of childbearing
- •potential who are not practicing double-barrier birth control
- •or who will not remain abstinent during the study and for
- •30 days following the last dose of study medication.
- •Abstinence will be permitted if it is confirmed and
- •documented at every study visit. If employing birth control,
- •two of the following precautions must be used: vasectomy,
- •tubal ligation, vaginal diaphragm, intrauterine
- •device (IUD), birth control pill, birth control depot
- •injections, birth control implant, condom or sponge with
- •spermicide.
- •2. Females who are breast-feeding and/or who have a positive
- •serum pregnancy test result prior to receiving study drug.
- •Target Disease
- •3. Subjects with a current DSM-IV-TR diagnosis other than
- •schizophrenia, including an Axis I (DSM-IV-TR) current
- •diagnosis of schizoaffective disorder or current diagnosis of
- •major depressive disorder, or bipolar disorder with or
- •without psychotic features. Also, subjects with any of the
- •following Axis II (DSM-IV-TR) diagnoses: borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial
- •personality disorder.
- •4. Subjects with a clinical presentation and/or history that is
- •consistent with delirium, dementia, amnesia or other
- •cognitive disorders; subjects with psychotic symptoms that
- •are better accounted for by another general medical
- •condition(s) or direct effect of a substance (i.e., medication,
- •illicit drug use, etc.).
- •5. Subjects with attention deficit disorder or attention deficit
- •hyperactivity disorder and/or the patient was on stimulant
- •treatment for any period of time over the last one year prior
- •to screening.
- •6. Subjects with a clinical presentation and/or history of any
- •neurodevelopmental disorder.
- •7. Subjects experiencing acute depressive symptoms within
- •the past 30 days prior to screening that require treatment
- •with an antidepressant, according to the investigatorâ??s
- •8. Subjects with schizophrenia that is considered treatment
- •resistant to antipsychotic medication, including relapse
- •while on adequate doses of aripiprazole, by history.
- •9. Subjects with a history of failure of clozapine treatment or
- •response to clozapine treatment only.
- •Medical History and Concurrent Disease
- •10. Subjects who have a significant risk of committing suicide
- •based on history (e.g., suicide attempt in the past 1 year) or
- •routine psychiatric status examination, or who have an
- •answer of â??yesâ?? on Questions 4 or 5 (current or over the
- 另有 8 项未显示
研究者
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